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The Therapeutic Efficacy of Neurofeedback in Depression (neurofeedback)

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ClinicalTrials.gov Identifier: NCT00729547
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : August 7, 2008
Sponsor:
Collaborators:
Korea Research Foundation
Kyunghee University
Information provided by:
Korea University

Brief Summary:
The investigators examined the therapeutic efficacy of neurofeedback in depression subjects. The investigators hypothesize that 5 weeks neurofeedback training will be able to alleviate depressive symptoms.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Neurofeedback Behavioral: Psychotherapy placebo Not Applicable

Detailed Description:

Subject

  • Fulfilled DSM-IV criteria for depressive disorders.
  • Persons who had organic disorders were excluded.
  • Who had been treated by psychoactive drugs for at least 2 months prior to the study were excluded.

Design

  • Subjects were randomly assigned to two groups (EEG biofeedback /psychotherapy placebo) by block randomization.
  • EEG biofeedback training was provided for 5 weeks(10 sessions, twice per week). Each training session was composed of 6 four minute trials followed by 5 thirty second rest periods
  • Psychotherapy placebo session was provided for 5 weeks. These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
  • After subjects completed the training, they participated in a month-long (twice per week) self-training session to maintain a similar mental state during neurofeedback training sessions without feedback system's assistance.
  • Subjects who had finished the psychotherapy placebo were referred to other therapists as necessary.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Therapeutic Efficacy of Frontal EEG Asymmetry Neurofeedback in Depression
Study Start Date : September 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 2
Psychotherapy placebo session
Behavioral: Psychotherapy placebo
These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
Experimental: 1
Neurofeedback training which enhance left frontal alpha wave.
Behavioral: Neurofeedback
enhance relative activity level of left frontal activity
Other Name: Asymmetry training



Primary Outcome Measures :
  1. frontal EEG asymmetry indexes [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. BDI-2 [ Time Frame: 5 weeks ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of mood disorder
  • right handed
  • current BDI-2 score exceed 10

Exclusion Criteria:

  • with psychotic symptom
  • with organic disorders
  • treated by psychoactive drugs for at least 2 months prior to the study
  • history of pathologic alcohol use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729547


Locations
Korea, Republic of
Department of Oriental Neuropsychiatry, Kyunghee Medical Center
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Korea University
Korea Research Foundation
Kyunghee University
Investigators
Principal Investigator: Hyuntaek Kim, PHD Department of Psychology, Korea university

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Hyun Taek Kim/Professor, Department of Psychology, Korea University
ClinicalTrials.gov Identifier: NCT00729547     History of Changes
Other Study ID Numbers: KRF-2005-079-HS0012
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: August 7, 2008
Last Verified: September 2006

Keywords provided by Korea University:
Depression
Biofeedback
Psychophysiology

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders